UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028528 |
|---|---|
| Receipt number | R000022955 |
| Scientific Title | A Comparative Review of Airwayscope and Styletscope in case of CVCI |
| Date of disclosure of the study information | 2017/08/03 |
| Last modified on | 2017/08/03 21:08:29 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Comparative Review of Airwayscope and Styletscope in case of CVCI
Acronym
A Comparative Review of Intubation devices in case of CSM
Scientific Title
A Comparative Review of Airwayscope and Styletscope in case of CVCI
Scientific Title:Acronym
A Comparative Review of Intubation devices in case of CSM
Region
| Japan |
Condition
Condition
cervical spondylotic myelopathy
Classification by specialty
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of the usefulness of the stylet scope
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The intubation time, and Change of vital signs, especially blood pressure, heart rate,and SpO2
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
We use an air way scope for tracheal intubation. We cancel a study three times when it is hard to intubate it even if it takes effect.
Interventions/Control_2
We use a stylet scope for tracheal intubation. We cancel a study three times when it is hard to intubate it even if it takes effect.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 45 | years-old | <= |
Age-upper limit
| 94 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients who receive a diagnosis of the cervical spondylotic myelopathy, and undergo cervical vertebrae laminoplasty
Key exclusion criteria
The patients who requried Subconscious fiber intubation, that an agreement was not obtained beforehand, are stage of more than ASA3
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | HIRANO HIROKO |
Organization
CHUBU ROSAI Hospital
Division name
Anesthesiology
Zip code
Address
1-10-6 Koumei Minatoku Nagoya City Aichi Prefecture
TEL
052-652-5511
hrk0203ykng@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | HIRANO HIROKO |
Organization
CHUBU ROSAI Hospital
Division name
Anesthesiology
Zip code
Address
1-10-6 Koumei Minatoku Nagoya City Aichi Prefecture
TEL
052-652-5511
Homepage URL
hrk0203ykng@gmail.com
Sponsor or person
Institute
Anesthesiology of CHUBU ROSAI Hospital
Institute
Department
Personal name
Funding Source
Organization
no
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2014 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 03 | Day |
Last modified on
| 2017 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022955
